f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Registry-Based Real-World Use Surveillance


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General
Study Status Study Pending
Application Number /
Requirement Number		 P230013 / PAS001
Date Original Protocol Accepted 02/01/2024
Date Current Protocol Accepted  
Study Name Registry-Based Real-World Use Surveillance
Device Name Edwards EVOQUE Tricuspid Valve Replacement System
General Study Protocol Parameters
Study Design Active Surveillance
Data Source External Registry
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Registry-Based Real-World Use Surveillance. The objective of the surveillance is to assess the real-world performance of the EVOQUE system and the clinical outcomes of the device in patient populations underrepresented in the TRISCEND II pivotal trial.
Study Population Patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, for whom tricuspid valve replacement is deemed appropriate by a heart team.
Sample Size All consecutive patients treated within the first 2 years following device approval or a total of 5,000 consecutively treated patients, whichever is greater, who are entered into the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry (enrollment period). Data collection will continue for underrepresented racial and ethnic groups (Black/African American, Asian, American Indian/Alaskan Native, Native Hawaiian/Pacific Islander, and Hispanic or Latino ethnicity) until each group has enrolled a minimum of 100 patients.
Key Study Endpoints The clinical data through one (1) year are collected through the TVT Registry. The follow-up data (including all-cause mortality, stroke, tricuspid valve reintervention, and hospitalization) from year 2 through year 5 post procedure are obtained through linking the TVT data with the Centers for Medicare and Medicaid Services (CMS) claims database.
Follow-up Visits and Length of Follow-up 5 years


Registry-Based Real-World Use Surveillance Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 01/31/2025    
2 year report 01/31/2026    
3 year report 01/31/2027    
4 year report 01/31/2028    


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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